BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (USOTCQB: BVAXF) (“BioVaxys” or “the Company”) is pleased to announce that its bioproduction partner Bio Elpida of Lyon, France, has initiated construction of a new Good Manufacturing Practice (“GMP”) clean room facility needed for producing clinical supply of BVX-0918A, BioVaxys’ ovarian cancer vaccine candidate.
The design, construction and qualification of the new facility will be dedicated to autologous cancer vaccine production for BioVaxys, allowing for ovarian tumor biopsy reception and treatment within a short time frame.
The GMP clean room facility is planned to be completed by the end of this year.
The bioproduction process development consists of two phases. The first phase, which has begun, is a feasibility study and involves the development of production techniques using BioVaxys know-how.
After establishing these techniques, Bio Elpida will further develop the required procedures, tests and assays over the next few months so that the product can be produced in compliance with GMP requirements.
Bio Elpida will work with BioVaxys to prepare the manufacturing section of the Clinical Trial Application (the “CTA,” which is similar to the US IND application) for the EU. Upon acceptance of the CTA, the second phase of the engagement would then commence, which is the manufacturing and testing of clinical samples for administration to patients as part of the EU clinical trial phase I/II planned for Q2 next year.
Bio Elpida President Gilles Devilliers stated that “Bio Elpida is excited and proud to contributing to BioVaxys’ pharmaceutical bioproduction process development of BVX-0918A for the European Phase I clinical. The construction of a dedicated GMP clean room facility for cancer vaccine production is well in line with Bio Elpida’s strategy to remaining a leader in this specific service offering.”